The Business of Diabetes - doctor nitpicks and bitches about "unpopular" "ethical guidelines," - interesting and enlightening reading
- From: "TC" <tunderbar@xxxxxxxxxxx>
- Date: 22 Jan 2007 09:12:38 -0800
http://clinical.diabetesjournals.org/cgi/content/full/23/1/6
The Business of Diabetes
The Coming Crisis in Continuing Education in Diabetes: Resolvable
Issues and Novel Solutions
Steven B. Leichter, MD, FACP, FACE
Introduction
Top
Introduction
The Need for CME...
Summary
REFERENCES
In a previous article,1 a broad theoretical concept was presented that
suggested that physician participation in continuing medical education
(CME) programs was diminishing and would continue to diminish. The
reasons suggested for this were:
Growing dependence on pharmaceutical companies for financial support of
CME programs
Increasing pressure for regulatory oversight of educational programs
sponsored by pharmaceutical companies
Increasing and negative imposition of "ethical standards" for physician
behavior by pharmaceutical companies in CME interactions
Despite regulatory oversight, growing pharmaceutical company control of
the development and marketing of physician "experts" for CME, whether
promotional or accredited
With increased regulatory oversight, a decline in the degree of
creativity and level of sophistication of such programs, converting
many CME or promotional programs into "infomercials."
According to unofficial but authoritative sources in various
pharmaceutical companies, these influences have resulted in a
substantial decline in physician participation in CME programs. Despite
these trends, there is no evidence that the current directions will be
altered in the near future. Altering these characteristics would be
very desirable in diabetes care.
The Need for CME in Diabetes Care
Top
Introduction
The Need for CME...
Summary
REFERENCES
Multiple studies have confirmed that the prevalent level of care for
diabetic patients is demonstrably deviant from recommended guidelines
and procedures.2-7 This has been documented in various care settings,
including primary care, family practice, and large urban managed care
organizations.
Despite vigorous efforts on the part of the American Diabetes
Association (ADA) and other organizations to remedy these deviations,
there is no compelling evidence that such efforts have substantially
improved these gaps in care. A study on the impact of the Canadian
Diabetes Association's clinical practice guidelines for postpartum
screening of pregnant women with gestational diabetes for type 2
diabetes demonstrated that the guidelines had no significant effect.8
The failure of such educational efforts in diabetes reflects a
widespread failure of CME efforts to improve clinical practice.9 Part
of this problem relates to the relevance and complexity of guidelines
or clinical practice recommendations and the ease with which these
changes in care patterns fit into existing practice.10
These issues emphasize areas of concern in professional education in
diabetes care. They underscore how important postgraduate physician
education in diabetes care is and how concerned we all should be about
declines in physician interest in such opportunities. They document how
important it is for educational efforts to be driven by physician need
and interest rather than by the self-interested agendas of outside
organizations or corporations. And they suggest that the imposition of
new obstacles to physician participation, such as unpopular "ethical
guidelines," must be modified to remove their barrier effect.
Barrier 1: Application of "Ethical Guidelines" on Postgraduate
Physician Education
As most health professionals know, major pharmaceutical companies,
through their professional organization Pharmaceutical Research and
Manufacturers of America (PhRMA), recently issued the PhRMA Code on
Interaction with Health Professionals."11 This extensive, 56-page
document covers a number of important issues regarding the ethical
interaction of companies with health professionals, including
interactions in the conduct of company-sponsored CME programs. This
year, the Advanced Medical Technology Association adopted a similar
code of conduct.12
The implementation of these guidelines has included certain key changes
in how physicians could participate in corporate-sponsored educational
programs. First, physicians' spouses or other guests who are not health
professionals or who have work responsibilities not clearly relevant to
the educational program cannot attend. This restriction is enforced by
most companies even if the attendees are willing to pay for whatever
food or beverages are provided to their guests at the program. Second,
companies cannot spend more than a "modest" amount of money on the food
or beverages at these programs. Third, health professionals can attend
out-of-town programs only if they are willing to accept "reasonable"
travel arrangements. Finally, guests may accompany health professionals
to out-of-town programs only if the professionals or guests pay for
whatever travel, food, and beverages are provided.
While these changes sound highly ethical and appropriate, it is one of
the most open secrets in the health care industry that, when
implemented, they have had an extremely negative effect on physician
participation in educational programs and physician attitudes toward
the process. Although many recognize pressure from the federal
government (specifically the Office of the Inspector General [OIG]) on
vendor companies to follow such guidelines, the manner in which they
are implemented may appear high-handed to many health professionals.
Regardless of cause, large PhRMA companies are imposing a code of
conduct on their health professional customers. But the hole in their
stance is that no other groups of customers or influential members of
the community are subjected to the same code of conduct.13,14 This
includes managers or executives of large managed care organizations,
pharmacy benefits executives, congressional staff, and elected
officials.
Perhaps the most controversial part of the codes, as they affect health
professionals, is their requirement that spouses or guests be excluded
from attendance, even if the health professionals pay for their guests'
meals. Informal but broad feedback from pharmaceutical representatives
of various companies indicates that this one stipulation has been the
most influential in discouraging physician participation at educational
programs. Whether this restriction is well-founded or not, it is
perhaps the single most important obstacle to health professional
attendance at educational programs.
There should also be concern about the application of rules regarding
attendance at out-of-town meetings. A previous article15 noted that the
engagement of third-party vendors by pharmaceutical companies may lead
to abuses. The potential for abuse, by which these vendors may increase
their profits, should be monitored carefully. In their zeal to
demonstrate forcefully that they are adhering to ethical guidelines,
PhRMA companies are allowing third-party vendors to charge attendees
exorbitant amounts for food and transportation to and from airports for
their spouses or other guests. At one recent educational conference,
the organizing vendor charged attendees more than $800 for two airport
transports and three meals for their spouses/guests. The same services
purchased directly would have cost only $280!
Another issue is whether travel restrictions imposed on conference
participants under the guise of these guidelines are truly required by
PhRMA guidelines. There is a fine line between ethical behavior and
poor treatment of health professionals.
A solution for these problems is clearly needed to improve enthusiasm
for educational conferences while adhering to the ethical requirements
of the OIG. Corporate advocacy of ethical conduct for health
professionals should be presented in a positive and cooperative
fashion, not in the high-handed directive fashion in which it is
presently offered. PhRMA companies should reconsider whether, under
ethical codes, health professionals may be permitted to bring spouses
or other guests to such programs. Each vendor may individually decide
whether providers should pay the food and beverage costs for their
guests. Third-party vendors of educational conferences should be
required to provide transportation, food, and beverages to attendees'
guests at their cost, not at an inflated estimation of what health
professionals should be charged. Making these changes should have a
positive effect on health professionals' willingness to participate in
corporate-sponsored programs.
This would benefit all concerned about diabetes care. Given the large
number of existing medical products and the number of new products that
will become available during the next 5 years, encouraging provider
access to educational programs should be a priority.
Barrier 2: Increasing Restrictions on Accredited Programs
On 28 September 2004, the Accreditation Council for Continuing Medical
Education (ACCME), under pressure from the OIG, announced strict new
guidelines regarding speaker involvement with vendor companies.16 All
parties involved in ACCME-approved programs have until May 2005 to
become compliant with these guidelines. Under these guidelines, any
individual who has any demonstrable financial relationship with a
corporate sponsor cannot help plan a program or speak on a subject
relevant to the products of that sponsor at an ACCME-accredited
program. Knowledgeable experts on CME programs believe that these
changes will alter professional education substantially.
One worry is that these efforts of the ACCME will exclude many
recognized experts from speaking about areas relevant to their
expertise. Pharmaceutical companies have had substantial influence in
developing and marketing experts on new therapies or devices. Also,
pharmaceutical companies are an important source of funding for ACCME
programs. Obviously, these new guidelines will encourage
ACCME-accredited programs and pharmaceutical companies to develop new
relationships for funding such programs and for developing credible
experts.
These changes are so new that no answers are yet apparent regarding how
diabetes CME will be affected. However, these changes may strengthen
the role of professional organizations, such as the ADA, in developing
experts. Such a development would clearly confer more independence in
professional education and emphasize the benefits of having ethical
organizations assume a greater role.
Summary
Top
Introduction
The Need for CME...
Summary
REFERENCES
Current trends in both objective restrictions and subjective attitudes
may be decreasing, rather than encouraging, provider participation in
educational programs. Amelioration of these trends may substantially
reduce these adverse effects. The introduction of new guidelines for
participation in planning or speaking at educational meetings will have
a profound effect on professional education. These changes may work to
strengthen the independence and objectivity of continuing education in
the long run.
Footnotes
Steven B. Leichter, MD, FACP, FACE, is co-director of the Columbus
Research Foundation and president of Endocrine Consultants, PC, in
Columbus, Ga. He is a professor of medicine at Mercer University School
of Medicine in Macon, Ga.
**********
http://www.endoconsult.net/about.cfm
http://www.endoconsult.net/hot-information.cfm
Hot info about obesity and no mention of nutrition, only pills and
hormones.
http://www.diabetesincontrol.com/modules.php?name=News&file=print&sid=2509
TC
.
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